Job Title: Officer QA (Process Validation)
If you are passionate about ensuring the quality and effectiveness of pharmaceutical products, this Officer QA (Process Validation) role at Eris Therapeutics is an ideal fit. With a strong focus on process validation, this position offers a dynamic work environment and ample opportunities for growth in the pharmaceutical quality assurance field.Key Responsibilities:
- BMR & BPR Review:
- Conduct thorough reviews of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) to ensure that all quality processes meet industry and company standards.
- Process Validation:
- Oversee and execute process validation activities to ensure that products are manufactured consistently within the required specifications.
- Hold Time Study:
- Conduct hold time studies to assess the stability of intermediate products during the production process and ensure their compliance with quality standards.
- Qualifications & Validation Activity:
- Ensure that all qualifications and validations of equipment, processes, and systems are carried out as per regulatory requirements and internal protocols.
Qualifications Required:
- Education:
- M.Sc, B.Pharm, or M.Pharm degree.
- Experience:
- 3-5 years of experience in process validation and quality assurance within the pharmaceutical industry.
- Skills:
- A deep understanding of process validation, hold time studies, and quality management systems.
- Strong knowledge of BMR and BPR review processes, with hands-on experience in validation and qualification activities.
Location: Eris Therapeutics' Bavla Plant in Ahmedabad.